10 mg / ml concentrate for solution for infusion
reslizumab
1. What CINQAERO is and what it is used for
What CINQAERO is
CINQAERO is a medicine that contains the active substance reslizumab (a monoclonal antibody ) which is a type of protein that recognizes and binds to a specific target substance in the body.
How CINQAERO works
CINQAERO blocks interleukin ‑5 ‑ activity and reduces the number of eosinophils in the blood and lungs. Eosinophils are white blood cells that are involved in asthmatic inflammation. Interleukin ‑5 is a protein produced by the body that plays an important role in asthmatic inflammation by activating eosinophils.
What CINQAERO is used for
CINQAERO is used to treat severe eosinophilic asthma in adult patients (18 years and older) when the condition is not well controlled despite high-dose treatment with inhaled corticosteroids with another asthma medicine. Eosinophilic asthma is a type of asthma that means that patients have too many eosinophils in their blood or lungs. CINQAERO is used with other medicines to treat asthma (inhaled corticosteroids plus other asthma medicines).
What are the benefits of CINQAERO?
CINQAERO reduces how often you may experience worsening asthma symptoms, helps you breathe better, and reduces your asthma symptoms.
2. What you need to know before you get CINQAERO
You should not receive CINQAERO:
- if you are allergic to reslizumab or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or nurse before receiving CINQAERO:
- if you have a parasitic infection or if you live in an area where parasitic infections are common or if you travel to such an area as this medicine may reduce your body’s ability to fight certain types of parasitic infections.
Also, talk to a doctor or nurse when receiving CINQAERO:
- if asthma is still out of control or if it worsens during treatment with this medicine.
- if you have any symptoms of an allergic reaction (eg itching, difficulty breathing, wheezing, fever, chills, dizziness, headache, nausea, vomiting, abdominal discomfort, rash, redness, or swelling). Serious allergic reactions have occurred in patients receiving this medicine (see section “4. Possible side effects”).
Children and young people
This is NOT for use in children and adolescents under 18 years of age.
Other medicines and CINQAERO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is especially important:
- if you are taking other medicines that affect the immune system
- if you have recently been vaccinated or if you are likely to need to be vaccinated.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The active substance in this medicine may pass into breast milk but only during the first days after birth.
Driving and using machines
CINQAERO is unlikely to affect your ability to drive and use machines.
CINQAERO contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
How CINQAERO is given
Always follow your doctor’s instructions. Ask your doctor or pharmacist if you are unsure.
Dose one depends on your body weight. The doctor will calculate which dose is right for you. The highest dose is 3 mg/kg body weight. CINQAERO is given every 4 weeks. CINQAERO is given by a doctor or nurse as an infusion (drip) into a vein. Infusion one takes about 20 to 50 minutes.
You may need more than one dose before your asthma symptoms improve.
Your doctor or nurse will monitor you closely during and after the infusion for signs of an allergic reaction.
If you miss a dose of CINQAERO
If you have missed a planned dose of CINQAERO, ask your doctor when you should receive the next treatment.
If you stop using CINQAERO
DO NOT stop treatment with CINQAERO unless your doctor tells you to, even if you feel better. If you stop or stop taking this medicine, your asthma symptoms may return.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
- Severe allergic reactions are uncommon (may affect up to 1 in 100 people) during or after administration of CINQAERO. Your doctor or nurse will monitor you closely for signs of a reaction. Tell your doctor or nurse immediately if you get any symptoms of an allergic reaction (eg itching, difficulty breathing, wheezing, fever, chills, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness, or swelling).
Other side effects are
Common (may affect up to 1 in 10 people)
- The increased amount of an enzyme in the blood (blood creatine phosphokinase)
Uncommon (may affect up to 1 in 100 people)
- Muscle pain ( myalgia )
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store CINQAERO
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton and label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Keep the vial in the outer carton. Sensitive to light.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is reslizumab.One ml concentrate contains 10 mg reslizumab (10 mg / ml). A vial of 2.5 ml contains 25 mg reslizumab and a vial of 10 ml contains 100 mg reslizumab.
- The other ingredients are sodium acetate, concentrated acetic acid, sucrose, and water for injections.
What the medicine looks like and the contents of the pack
CINQAERO is a clear to slightly opalescent, colorless to light yellow concentrate for solution for infusion (sterile concentrate). Particles may be present. CINQAERO is supplied in glass vials containing 2.5 ml or 10 ml.
CINQAERO is available in packs containing 1 or 2 2.5 ml vials and in packs containing 1 or 2 10 ml vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Teva BV
Swensweg 5
2031 GA Haarlem
Netherlands
Manufacturer
UAB Teva Baltics
Molėtų pl. 5
LT ‑ 08409 Vilnius
Lithuania
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel: +32 3 820 73 73 | LithuaniaUAB Teva BalticsTel: +370 5 266 0203 |
| BulgariaTeva Pharmaceuticals Bulgaria ЕООДTel: +359 2 489 95 82 | Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AGTel: +32 3 820 73 73 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251 007 111 | HungaryTeva Gyógyszergyár Zrt.Tel .: +36 1 288 64 00 |
| DenmarkTeva Denmark A / STel: +45 44 98 55 11 | MaltaTeva Pharmaceuticals Ireland, L ‑ IrelandTel: +353 51 321740 |
| GermanyTEVA GmbHTel: +49 731 402 08 | The NetherlandsTeva Nederland BVTel: +31 800 0228 400 |
| EestiUAB Teva Baltics Eesti subsidiaryTel: +372 661 0801 | NorwayTeva Norway ASTel: +47 66 77 55 90 |
| GreeceTeva Αλλάς Α.Ε.:Ηλ: +30 211 880 5000 | Austriaratiopharm Arzneimittel Vertriebs ‑ GmbHTel: +43 1 97 007 |
| SpainTeva Pharma, SLUTel: +34 91 387 32 80 | PolandTeva Pharmaceuticals Polska Sp. z ooTel .: +48 22 345 93 00 |
| FranceTeva HealthTel: +33 1 55 91 78 00 | PortugalTeva Pharma – Pharmaceutical Products, LdaTel: +351 21 476 75 50 |
| CroatiaPliva Hrvatska dooTel: +385 1 37 20 000 | RomaniaTeva Pharmaceuticals SRLTel: +40 21 230 65 24 |
| IrelandTeva Pharmaceuticals IrelandTel: +353 51 321740 | SloveniaPliva Ljubljana dooTel: +386 1 58 90 390 |
| IcelandVistor hfPhone: +354 535 7000 | Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 2 57 26 79 11 |
| ItalyTeva Italia SrlTel: +39 02 89 17 98 1 | Finland / FinlandTeva Finland OyPuh / Tel: +358 20 180 5900 |
| ΚύπροςTeva Αλλάς Α.Ε., .λλάδα:Ηλ: +30 211 880 5000 | |
| LatviaUAB Teva Baltics subsidiary LatvijāTel: +371 673 23 666 | UKTeva UK LimitedTel: +44 1977 628500 |